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Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study (MIDAS)

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ClinicalTrials.gov Identifier: NCT04238494
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE August 19, 2019
First Posted Date  ICMJE January 23, 2020
Last Update Posted Date October 20, 2021
Actual Study Start Date  ICMJE October 18, 2019
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
Fat involution and trophicity in rectus femoris [ Time Frame: day 1 ]
percentage of the rectus femoris lipid of both leg (dominant and non-dominant) in frail and pre-frail older subject and in non-frail older subjects (MRI with T1)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • description of brain by MRI [ Time Frame: day 1 ]
    description of MRI brain correlates of frailty and assessment of their sensibility / specificity with regards to Fried's frailty syndrome in a population older than 70y with at least 25% of subjects frail and 25% pre-frail and none with high level of daily living dependency.
  • Evaluation of inflammation grade [ Time Frame: day 1 ]
    description of muscle/brain MRI correlates of frailty and assessment of their sensibility / specificity with regards to Fried's frailty syndrome in a population with low/medium grade inflammation (HsCRP>3mg/L), older than 70y as compared to other subjects
  • measure the myostatin rate [ Time Frame: day 1 ]
    To explore the role of Myostatin in the regulation loop of muscle function during frailty
  • measure the cystatin-C and creatinine rate [ Time Frame: day 1 ]
    Determine the associations between muscle alterations seen on MRI and glomerular filtration rate estimated using serum cystatin-C or creatinine
  • measure the serum interleukin IL-1b and IL-18 rate [ Time Frame: day 1 ]
    Determine the associations between muscle alterations seen on MRI and serum IL-1b and IL-18.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study
Official Title  ICMJE Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study
Brief Summary

Frailty is a multideterminant syndrome in which muscle function appears to play a central role. Muscle function depends on brain control, nutrition and perfusion. We hypothesized that multiparametric MRI assessment combined with comprehensive gerontological assessment (CGA) and routine biological assessment of inflammation in a sample of older people with and without diabetes will allow to explore on one side the possibilities of multi-parametric MRI muscle and brain imaging to describe the correlates of frailty and on the other side will describe the different muscle/brain alterations due to diabetes in frailty.

The main objective is to compare the lipid percent of the rectus femoris in frail and pre-frail older subjects and in non-frail older subjects.

Detailed Description

Frailty concept has been created to screen the older people at risk for dependency and to propose preventive intervention. Muscle function is at the centre of the concept and the majority of interventions proposed to reverse or to prevent frailty have targeted physical function. Anatomical and functional alteration of muscle, called sarcopenia is defined as a low skeletal muscle mass, a decrease in strength (dynapenia or sarcopenia is the age-associated loss of muscle strength that is not caused by neurologic or muscular diseases) and functional consequences such as low gait speed. Qualitative analysis should be associated with quantitative (mass) analysis in older subjects assessed for frailty. Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI) can be used for this purpose. Brain changes were also reported to be associated with frailty. The study of structural changes associated with brain MRI alterations may better explain the frailty process.

Robust, frail and pre-frail subjects will be compared for clinical and MRI data. Grey matter volumes, white matter hyperintensities, diffusion tensor imaging data and muscle assessments relationships will be described After baseline assessment follow-up will be performed by phone calls after one month and after six months to record the number of falls and severity, the number of unscheduled hospitalization, the admission in institution for older people and death.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Multicomponent assessment: clinical, biological, functional, cognitive and MRI (muscle and brain)
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Frail Elderly Syndrome
  • Diabetes
Intervention  ICMJE Diagnostic Test: Nuclear magnetic resonance (NMR)
Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI)
Study Arms  ICMJE
  • Experimental: Frail/prefrail
    Fried's criteria >3 = frail, 1 or 2 = prefrail The 5 Fried criteria mainly target the muscle function: low muscle strength, decreased physical activity and low gait speed. One refers to depressive symptoms with the use of 2 CES-D (Centre for Epidemiologic Studies - Depression Scale) questions and one to nutrition with the weight loss criteria. The second most famous definition of frailty was developed by ROCKWOOD and MITNISIKI (2). It describes frailty as the accumulation of deficits including cognitive, functional and social alterations
    Intervention: Diagnostic Test: Nuclear magnetic resonance (NMR)
  • non frail
    No Fried's criteria
    Intervention: Diagnostic Test: Nuclear magnetic resonance (NMR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2022
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Robust or frail or pre-frail with at least 25% frail and 25% pre-frail according to Frieds criteria
  • Barthel index > or = 60/100
  • With or without diabetes mellitus, 45 to 55 % with known diabetes mellitus
  • With no contraindication to undergo an MRI examination

Exclusion Criteria:

  • not willing to participate
  • not able to give informed consent or to understand basic instruction due to any problem (sensorial, educational, language)
  • without social insurance
  • with a legal protection
  • with significant cognitive alteration (MMSe<21/30 or in case of low literacy <19/30)
  • with a recent (2 month period) severe event: hospitalization, sepsis, stroke even with complete recovery, trauma
  • with stroke sequelae (motor, speech)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Isabelle BOURDEL-MARCHASSON, MD,PhD +33 (0)5 57 65 65 71 isabelle.bourdel-marchasson@chu-bordeaux.fr
Contact: Fara RATSIMBAZAFY +33(0)5 57 65 65 71 fara.ratsimbazafy@chu-bordeaux.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04238494
Other Study ID Numbers  ICMJE CHUBX 2019/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isabelle BOURDEL-MARCHASSON, MD, PhD University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP